Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa

NCT07689188 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: ARQ-MA-000260
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the efficacy of topical roflumilast foam in patients with HS.

Conditions

Hidradenitis Suppurativa (HS)

Keywords

HS

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16

  Mean change from baseline in the total abscess and inflammatory nodule (AN) count. AN count is the total number of abscesses and inflammatory nodules assessed at baseline and week 16.

  Baseline and Week 16

Study Arms (1)

Roflumilast Foam 0.3

EXPERIMENTAL

Experimental: Roflumilast 0.3% topical foam Roflumilast 0.3% topical foam to be applied QD to all active fields for the duration of the 16-week trial. Interventions: Drug: Roflumilast 0.3% topical foam

Drug: Roflumilast 0.3% topical foam

Interventions

Roflumilast 0.3% topical foam DRUG

Roflumilast 0.3% topical foam applied once daily (QD) to all active hidradenitis suppurativa lesions for 16 weeks.

Roflumilast Foam 0.3

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 12 years or older at time of consent (or assent).
• Participants and/or legal guardians are legally competent to sign and give informed consent or assent (for adolescents).
• Diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 3 months.
• Diagnosis of HS (Hurley Stage I or II) with a total abscess and inflammatory nodule (AN) count of at least 4 to ≤10, with no draining tunnels at screening and baseline visits, affecting at least one distinct anatomical region.
• Agreement to NOT use topical and systemic antibiotics and intralesional steroids for treatment of HS during the study.
• Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study.
• Subjects who have had surgery in the treatment area must be at least 3 months post-procedure (applies to deroofing/marsupialization or excision, not incision and drainage).
• Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline/Day 1 and agree to use at least one highly effective or barrier method of contraception throughout the study.
• Females of non-childbearing potential must be premenarchal, postmenopausal (≥12 months spontaneous amenorrhea), or surgically sterile.
• In good health as judged by the Investigator based on medical history, targeted physical examination, and vital signs. Subjects and parent(s)/legal guardian(s) must be reliable and capable of adhering to the protocol and visit schedule.

You may not qualify if:

• Medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
• Inability to discontinue prohibited medications or treatments before Baseline or during the study.
• Presence of draining tunnels at Screening or Baseline.
• Unwillingness to refrain from prolonged sun exposure or tanning beds/other artificial light-emitting devices for 4 weeks before Baseline and during the study.
• Skin conditions other than HS that could interfere with evaluation of study medication.
• Conditions in the treatment area that could confound efficacy measurements.
• Known allergy to excipients in roflumilast foam.
• Use of oral roflumilast (Daxas® or Daliresp®) within 4 weeks before Baseline.
• History of severe depression, suicidal ideation, or suicidal behavior at Screening/Baseline.
• Pregnant, planning pregnancy during the study, or breastfeeding.
• Previous treatment with roflumilast cream or foam or current roflumilast use for another indication expected to continue during the study.
• Major surgery within 4 weeks before Baseline or planned during the study.
• History of chronic alcohol or drug abuse within 6 months before Screening.
• History of cancer within 5 years, except fully treated basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix.
• Parent(s)/legal guardian(s) or subjects unable to communicate, read, or understand the local language, or otherwise unsuitable for participation in the Investigator's opinion.

Sponsors & Collaborators

• Harrison Dermatology: lead

Study Sites (1)

Harrison Dermatology

Missouri City, Texas, 77459, United States

Location

Related Links

• https://medlineplus.gov/hidradenitissuppurativa.html
• https://dailymed.nlm.nih.gov/dailymed/

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• HARRISON NGUYEN, MD, MBA, MPH, FAAD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harrison Nguyen, MD, MBA, MPH, FAAD

CONTACT

346.771.3990; harrison.nguyen@harrisonderm.com

Amina Caballero, SCRC, PM

CONTACT

346.771.3990; amina.caballero@harrisonderm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): March 10, 2028
• Study Completion (Estimated): December 10, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)